Patients with histologically documented, locally advanced (stage IIIB with either pleural effusion or supra-clavicular nodal disease) or metastatic (stage IV) or recurred after an adjuvant treatment NSCLC. MedDRA version: 9.1 Level: LLT Classification code 10059515 MedDRA version: 9.1 Level: PT Classification code 10029521
Conditions
Interventions
Trade Name: NICETILE
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Acetylcarnitine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 590-
Pharmac
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female = 18 - No previous CHT or targeted therapies. Previous adjuvant or neo-adjuvant treatment is permitted if completed = 6 months before study inclusion. - ECOG performance status 0-1 - Adequate organ functions defined as follows: - Neutrophils ? 1.5 x 109/L, platelets 100 x 109/L, and hemoglobin = 9 g/dL - Bilirubin level either normal or ? 1.5 x ULN - ASAT and ALAT ? 2.5 x ULN (? 5 x ULN if liver metastasis are present) - Serum creatinine ?1.5 x ULN - Written informed consent given before the randomization, according to International Conference on Harmonization/Good Clinical Practice (ICH/GCP) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Symptomatic brain metastases - Any investigational agent(s) within 4 weeks prior to study entry - Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months - Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease - Patients with known allergy to any other components of the study drugs - History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complication - Known drug abuse/ alcohol abuse - Legal incapacity or limited legal capacity - Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent - Clinically relevant peripheral neuropathy - Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (Patients with a previous malignancy but without evidence of disease for ? 5 years will be allowed to enter the trial) - Pregnancy or breast feeding. Women of childbearing potential and their parents must be willing to practice acceptable methods of birth control to prevent pregnancy - Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare toxicity free survival of patients treated with ALC plus cisplatin-containing CHT versus those treated with placebo plus cisplatin-containing chemotherapy.;Secondary Objective: To compare: ? progression free survival ? overall survival ? the compliance to treatment ? the number of episodes of grade 3-4 National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 ? neurotoxicity, as well as the proportion of patients experiencing grade 2-3-4 National Cancer Institute Common Terminology Criteria for Adverse Events ? neuropathic pain intensity ? the clinical signs and/or symptoms (such as burning, numbness, itching, etc.) of the sensorial neuropathy between the two treatment arms.;Primary end point(s): The primary efficacy endpoint is toxicity-free survival, defined as the time from randomisation up to the occurrence of related to treatment grade 2-3-4 NCI-CTCAE neurotoxicity, progression, second primary malignancy, death from any cause, whichever comes first. Subjects who have not experienced related to treatment grade 2-3-4 toxicity, and not progressed or died while on study will be censored at their last assessment date. | — |
Countries
Italy
Outcome results
None listed